A national survey of policies on disclosure of conflicts of interest in biomedical research.

BACKGROUND: Conflicts of interest pose a threat to the integrity of scientific research. The current regulations of the U.S. Public Health Service and the National Science Foundation require that medical schools and other research institutions report the existence of conflicts of interest to the funding agency but allow the institutions to manage conflicts internally. The regulations do not specify how to do so. METHODS: We surveyed all medical schools (127) and other research institutions (170) that received more than $5 million in total grants annually from the National Institutes of Health or the National Science Foundation; 48 journals in basic science and clinical medicine; and 17 federal agencies in order to analyze their policies on conflicts of interest. RESULTS: Of the 297 institutions, 250 (84 percent) responded by March 2000, as did 47 of the 48 journals and 16 of the 17 federal agencies. Fifteen of the 250 institutions (6 percent)--5 medical schools and 10 other research institutions--reported that they had no policy on conflicts of interest. Among the institutions that had policies, there was marked variation in the definition and management of conflicts. Ninety-one percent had policies that adhered to the federal threshold for disclosure ($10,000 in annual income or equity in a relevant company or 5 percent ownership), and 9 percent had policies that exceeded the federal guidelines. Only 8 percent had policies requiring disclosure to funding agencies, only 7 percent had such policies regarding journals, and only 1 percent had policies requiring the disclosure of information to the relevant institutional review boards or to research subjects. Twenty journals (43 percent) reported that they had policies requiring disclosure of conflicts of interest. Only four federal agencies had policies that explicitly addressed conflicts of interest in extramural research, and all but one of the agencies relied primarily on institutional discretion. CONCLUSIONS: There is substantial variation among policies on conflicts of interest at medical schools and other research institutions. This variation, combined with the fact that many scientific journals and funding agencies do not require disclosure of conflicts of interest, suggests that the current standards may not be adequate to maintain a high level of scientific integrity.

Physicians' legal defensiveness and knowledge of medical law: comparing Denmark and the USA.

The impact of legal factors on medical treatment decisions for dying patients has been studied in the USA for years. However, it is unknown how legal factors may affect similar medical decisions in other countries. This exploratory study compared responses between two populations of physicians, from Denmark (n = 62) and the USA (n = 301), who regularly treat terminally ill patients in tertiary care medical centers. We investigated whether Danish and US physicians differed significantly in their attitudes about the influence of law on treatment decisions for terminally ill patients. The Danish physicians demonstrated significantly better knowledge of medical law relevant to end-of-life treatment than did US physicians. The Danish sample also reported significantly lower levels of legal defensiveness than the US sample. These findings are consistent with our previous research showing that, among US physicians, legal defensiveness and knowledge of medical law are inversely related.

Medical futility decisions and physicians' legal defensiveness: the impact of anticipated conflict on thresholds for end-of-life treatment.

Does legal defensiveness significantly influence physicians' assessments of medical futility, in ways that may adversely affect the rights of patients and their family members to make their own health care decisions at the end of life? This exploratory study addresses that question with attitudinal data from a survey of 301 physicians practicing in academic medical centers in Texas. The majority of respondents indicated that the probability of success defining futile treatment should hypothetically be lower for patients with potential to benefit more from life-sustaining medical intervention (e.g. typically patients who are sentient), and higher for patients with less potential to benefit (e.g. patients in a persistent vegetative state). That is to say, physicians normally perceive longer odds to be worth pursuing for greater potential gain - a position that seems logically consonant with patients' rational self-interest. However, physicians with an attitude of extreme legal defensiveness did not fit this pattern. Rather, they tended to define futility in a manner that would maximize the physician's latitude to justifiably oppose patient preferences for end-of-life treatment abatement. These findings suggest that some physicians assume an adversarial position in their consideration of medical futility issues - an attitude that anticipates conflict with terminally-ill patients or their surrogates. The analysis presented here is not definitive, but at least raises the question of whether some physicians may inappropriately use their prerogative over medical futility as a means to guard their professional autonomy against perceived threats.

Treatment refusal by an elderly man suffering intensely from treatment-resistant depression.

The authors consider the ethical issues involved in a case in which an elderly man suffering from recurrent, treatment-resistant depression expressed a wish to forgo life-sustaining treatment should it become necessary. The patient had no immediate life-threatening medical conditions but was in danger of becoming malnourished and dehydrated. The authors conclude that unrelieved suffering resulting from depression, when combined with repeated treatment failures, may justify refusal of life-sustaining treatment in very rare cases.

Ethical and practical implications of the human genome initiative for family medicine.

Major advances in predictive genetic testing resulting from the Human Genome Initiative could change significantly the routine practice of family medicine. Family physicians should be aware that increased genetic information may affect patients' abilities to acquire and maintain insurance and employment and that interested parties will have incentives to seek this information. The social consequences of genetic information, as well as increased health promotion efforts, may raise problems of informed consent and confidentiality. In addition to their ethical implications, these developments will also affect the practice of family physicians in practical ways such as record keeping. We discuss cases that illustrate the potential impact of these emerging technologies on the practice of family medicine.

Insurance and genetic testing: where are we now?

Basic research will spur development of genetic tests that are capable of presymptomatic prediction of disease, disability, and premature death in presently asymptomatic individuals. Concerns have been expressed about potential harms related to the use of genetic test results, especially loss of confidentiality, eugenics, and discrimination. Existing laws and administrative policies may not be sufficient to assure that genetic information is used fairly. To provide factual information and conceptual principles upon which sound social policy can be based, the Human Genome Initiative established an Ethical, Legal, and Social Issues Program. Among the first areas to be identified as a priority for study was insurance. This paper provides a review of life, health, and disability insurance systems, including basic principles, risk classification, and market and regulatory issues, and examines the potential impact of genetic information on the insurance industry.

Hospital policy on advance directives. Do institutions ask patients about living wills?

Surveys have shown that a substantial proportion of the population has prepared an advance directive. The purpose of this exploratory study was to assess the existence and nature of hospital policy regarding these documents. A survey questionnaire was sent to 394 randomly selected hospitals in the United States. Of the 219 responding hospitals, 146 (67%) reported having a formal policy regarding advance directives. The large majority of those with a policy require the patient to notify the hospital of an advance directive, while only 4% of the respondents actively inquire about these documents. Hospitals in states with legislation that sanctions advance directives were significantly more likely to have a formal policy regarding these documents than hospitals in states without such legislation. Forty-six percent of the respondents reported having an ethics committee; however, the presence of an ethics committee was not significantly associated with the presence of a formal policy. Of the 69 hospitals that had both a formal policy and an ethics committee, only 30 (43%) reported that the policy had been reviewed by the ethics committee. Ethical and legal issues regarding hospital policy on advance directives are discussed. Hospitals should adopt formal policies to ask all adult patients at the time of admission whether they have prepared a living will, durable power of attorney, or similar document; and ethics committees should play a more active role in policy development.

KIE: Hospitals throughout the United States were surveyed in 1988 to determine their policies on advance directives, including living wills and durable power of attorney documents. Sixty-seven percent of the 219 respondents reported some formal policy regarding advance directives. Most institutions made it the patient's responsibility to notify physicians of the existence of a directive, with only 4% of the hospitals querying the patient directly about an advance directive. State legislation on advance directives correlated positively with the drafting of a formal policy by hospitals, whereas the existence of an institutional ethics committee appeared to have no effect on whether a hospital had a formal policy on directives. The authors comment on the legal and ethical aspects of hospital policies on advance directives, and argue that all acute-care hospitals should establish a formal policy regarding directives and should ask patients upon admission if a directive has been completed.